RespirAI US Inc
The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age \>21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.
Inclusion Criteria: * Age \>21 years. * Physician-diagnosed COPD at least 6 months prior to screening visit. * Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months. * Free of exacerbation for 1 month before enrollment. Exclusion Criteria: * Unable or willing to sign an informed consent. * Unable to complete the 6-minute walk test due to physical or mental health conditions. * Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices. * Pregnancy * Study clinician determines that the patient is unable or u…
Use of a software-based monitoring device for 6 months.
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